Preterm
Conditions
Keywords
non-invasive ventilation, preterm infant, suction, pain, physological parameters
Brief summary
Background: Non-invasive ventilation (NIV) in preterm infants often leads to secretion-related airway obstructions, requiring suctioning. Traditional oro/nasopharyngeal suction techniques may cause mucosal trauma, pain, and physiological instability. Objective: To evaluate the effects of a novel non-traumatic oro/nasopharyngeal suction technique on physiological and behavioral parameters in preterm infants receiving NIV. Methods: A randomized controlled trial was conducted with 100 preterm infants (32 0/6 - 36 6/7 weeks gestation) admitted to a Level IV NICU. Infants were randomized into intervention (non-traumatic suction) and control (routine suction) groups. Data on heart rate, respiratory rate, SpO₂, skin color, and pain/sedation scores (N-PASS) were collected before, during, and after suctioning.
Detailed description
This randomized controlled clinical trial was conducted to evaluate the effectiveness of a newly developed non-traumatic oro/nasopharyngeal suction technique in preterm infants receiving non-invasive ventilation (NIV). Traditional suction methods used to remove airway secretions in neonates are often associated with complications such as mucosal trauma, bradycardia, hypoxia, and increased pain. The non-traumatic technique involves administering a small volume of sterile saline through one nostril and using gentle suction from the other nostril or the mouth without direct mucosal contact. This approach is designed to minimize trauma and discomfort. A total of 100 preterm infants with gestational ages between 32 0/6 and 36 6/7 weeks were included and randomized into two groups: an intervention group receiving the non-traumatic suction method and a control group undergoing standard suction. Key outcome measures included physiological parameters (heart rate, respiratory rate, SpO₂, skin color) and behavioral indicators assessed using the Neonatal Pain, Agitation, and Sedation Scale (N-PASS). Data were collected before, during, and after suctioning procedures.
Interventions
PROCEDURENon-Traumatic Nasopharyngeal Suction Procedure
A modified suctioning technique that avoids deep catheter insertion and minimizes mucosal contact. Sterile saline (0.9%) is instilled into one nostril, and secretions are aspirated using external suction via the opposite nostril or mouth. This approach is designed to reduce pain and physiological stress compared to standard suction methods in preterm infants undergoing non-invasive ventilation.
Sponsors
Istanbul Bilgi University
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Investigator)
Masking description
Single (Investigator)
Intervention model description
Parallel Assignment Randomized Controlled two groups (control group and study group)
Eligibility
Sex/Gender
ALL
Age
32 Weeks to 37 Weeks
Healthy volunteers
Yes
Inclusion criteria
Gestational age between 32 0/6 and 36 6/7 weeks Receiving non-invasive ventilation (NIV) via nasal CPAP Clinically stable prior to suctioning Parental or legal guardian informed consent obtained Age within first 7 days of life at time of first suction procedure
Exclusion criteria
Major congenital anomalies (e.g., craniofacial malformations, cardiac defects) Suspected or confirmed neurological disorders (e.g., intraventricular hemorrhage Grade III/IV) Presence of upper airway obstruction or nasal anomalies Infants requiring invasive mechanical ventilation at the time of study Any condition requiring continuous sedation or analgesia Hemodynamically unstable infants (e.g., hypotension requiring inotropes) Parental refusal or withdrawal of consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Pain Score During Suctioning, N-PASS (Neonatal Pain, Agitation, and Sedation Scale) pain subscore | During suctioning (within 1 minute of procedure start) | To evaluate and compare the level of pain experienced by preterm infants during suctioning using either the non-traumatic or standard technique. Pain Subscore: Range = 0 to 10, higher score = more pain. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Oxygen Saturation (SpO₂) During and After Suctioning | During suctioning and 10 minutes post-procedure. SpO₂ measured by pulse oximetry. | To assess the impact of suction technique on oxygenation stability. |
| Change in Heart Rate (HR) During and After Suctioning | During suctioning and 10 minutes post-procedure. Heart Rate measured using bedside monitor. | To compare the effect of suction methods on cardiovascular stability. |
| Change in Sedation Score During Suctioning,N-PASS sedation subscore, | During suctioning | To measure the behavioral reponse and comfort level of the infant during the procedure. Sedation Subscore: Range = -2 to +2, lower = deeper sedation |
Countries
Turkey (Türkiye)
Outcome results
None listed